TMF Process Lead

Are you passionate about Trial Master File processes, digital solutions, and global stakeholder collaboration?We are looking for a TMF Process Lead to take responsibility for operational TMF processes and help ensure simple, risk-based, and user-focused ways of working across our global organisation.In this role, you will act as a key liaison between Trial Operation, Clinical Operations, eTMF Leads/SMEs, COSMOS product teams, and other stakeholders contributing to the TMF. You will help identify and analyse business needs, drive process improvements, support best practice implementation, and explore opportunities for AI enablement within TMF management.

The positionAs TMF Process Lead, you will be responsible for operational TMF processes, including instructions, guidance, SharePoint sites, and training materials. You will support the continued development and optimisation of TMF practices in close collaboration with business stakeholders and digital product teams.Your key responsibilities will include:

Acting as a recognised TMF subject matter expert and sparring partner for eTMF Leads and business stakeholders

Identifying, analysing, and prioritising business needs using a simplicity mindset and risk-based approach

Creating and implementing best practices for eTMF users in collaboration with COSMOS product teams

Translating business needs into clear requirements and bridging the gap between end users and technical experts

Supporting implementation of external TMF requirements and aligning them with [xxxxx] TMF processes

Driving improvements in methods, tools, training, and guidance for TMF users

Analysing trends in SOP deviations, inspection and audit findings, and recommending actions when needed

Providing inspection and audit support to trial teams

Coordinating TMF integration related to FSO and M&A trials

Keeping up to date with external requirements, industry trends, and opportunities for innovation, including AI

The role is based in Denmark, with a global scope, and occasional international travel may be required.

QualificationsTo succeed in this role, you should have:

A master’s degree with at least 2 years of relevant experience, or an academic bachelor’s degree/equivalent combined with at least 4 years of relevant experience

Experience from a project-oriented, international organisation

Experience working cross-functionally across organisational areas

Solid stakeholder management skills

Knowledge of TMF management and clinical development processes

Strong analytical and problem-solving skills

Good understanding of digital solutions, data concepts, and the role of technology in business processes

Fluency in written and spoken English

As a person, you areCurious, proactive, and motivated by continuous improvement. You have a critical-thinking mindset and are able to connect the dots across complex information. You enjoy collaborating with others, sharing knowledge, and creating practical solutions that support end users and business needs.You communicate clearly and can translate complex technical topics into language that different stakeholder groups can understand and act on. You are comfortable facilitating discussions, constructively challenging stakeholders, and guiding teams toward the best solutions.

About the departmentClinical and Biosample Operations Office is a HQ-based function within Clinical Operations, driving operational excellence in clinical trials and central biosample management through strong cross-functional collaboration.What we offerThere is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.Salary: For this role, the Annual Base Salary ranges from 651.000 to 955.992 DKK (DK), corresponding to the level of the position.The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.Learn more about our Reward Philosophy hereWorking at [xxxxx]At [xxxxx], we use our skills, dedication, and ambition to help improve the lives of patients. We work in a global and collaborative environment where continuous improvement, innovation, and quality are central to everything we do.ContactFor further information, please contact Trine Kjær Laigaard at[xxxxx].Deadline16. June 2026We commit to an inclusive recruitment processAt [xxxxx], we are committed to creating an inclusive culture that celebrates the diversity of our employees, patients, and communities. Together, we are life changing.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At [xxxxx], we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.